BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS SHOE

    MDR report key: 12922535 · Received December 3, 2021

    Report

    Report Number
    3005180920-2021-00940
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040736206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-NOV-2021. LOT 1951510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED ON THE SAME LOT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. DISTAL FIBULAR FRACTURE HAS PROBABLY OCCURRED DURING THA SURGERY, WHERE A LEG POSITIONER WAS USED. THE LEG POSITIONER IS A MANUAL INSTRUMENT AND A BONE FRACTURE, ESPECIALLY IN ELDERLY OSTEOPOROTIC PATIENTS, IS AN ADVERSE EVENT THAT CAN OCCUR EVEN IF NO MALFUNCTION OF THE DEVICE OCCURRED.

    Description of Event or Problem · 0

    AN ANKLE BONE FRACTURE HAS BEEN DISCOVERED IN A PATIENT OPERATED WITH THE AMIS LEG POSITIONER. IT IS UNKNOWN IF THE FRACTURE HAPPENED DURING THE SURGERY, IT WAS DISCOVERED DURING THE RECOVERY PERIOD. THE PATIENT HAS NOW A SPLINT TO HOLD THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823940 AMIS SHOE INSTRUMENT FOR HIP SURGERY LXH MEDACTA INTERNATIONAL SA 01.15.10.0315 1951510 07630040736206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other